Overview

This trial is active, not recruiting.

Conditions dengue fever, dengue hemorrhagic fever
Treatments cyd dengue vaccine, nacl + cyd dengue vaccine
Phase phase 2
Sponsor Sanofi Pasteur, a Sanofi Company
Start date May 2016
End date February 2020
Trial size 1050 participants
Trial identifier NCT02628444, CYD65, U1111-1161-3242

Summary

The aim of the study is to assess the safety of the primary series vaccine schedules and the booster vaccination

Primary Objectives:

- To demonstrate the non-inferiority of the immune response elicited against each dengue serotype by tetravalent CYD vaccine given as a 2 dose schedule (Placebo 1/CYD Dengue vaccine group) compared to the immune response elicited by CYD vaccine given as a 3 dose schedule (CYD Dengue vaccine group) 28 days post-final vaccination.

- To demonstrate the non-inferiority of the immune response elicited against each dengue serotype by tetravalent CYD vaccine given as a 1 dose schedule (Placebo 2/CYD Dengue vaccine group) compared to the immune response elicited by CYD vaccine given as a 3 dose schedule (CYD Dengue vaccine group) 28 days post final vaccination.

- To demonstrate the non-inferiority of the immune response elicited against each dengue serotype 28 days after administration of a single booster dose of tetravalent CYD vaccine

Secondary Objectives:

- To demonstrate the superiority of the immune response elicited by tetravalent CYD vaccine given as a 2 dose schedule (Placebo 1/CYD Dengue vaccine group) compared to the immune response elicited by CYD vaccine given as a 3 dose schedule (CYD Dengue vaccine group) 28 days post-final vaccination.

- To demonstrate the superiority of the immune response elicited by tetravalent CYD vaccine given as a 1 dose schedule (Placebo 2/CYD Dengue vaccine group) compared to the immune response elicited by CYD vaccine given as a 3 dose schedule (CYD Dengue vaccine group) 28 days post-final vaccination.

- To describe the neutralizing antibody levels of each dengue serotype at 28 days post Dose 3 to the Ab levels immediately before receiving booster injection in all 3 CYD vaccination groups.

- To describe the neutralizing antibody levels of each dengue serotype at 28 days post-dose 2 and 28 days post-dose 3 from CYD Dengue vaccine group in a primary series schedule.

- To demonstrate the superiority of the immune response elicited against each dengue serotype 28 days after administration of a single booster dose of tetravalent CYD vaccine.

- To evaluate the safety profile of CYD vaccine after each and any injection

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
Participants randomized to receive 3 doses of CYD Dengue vaccine
cyd dengue vaccine
0.5 mL, Subcutaneous at Day 0, 6 and 12 months, respectively
(Experimental)
Participants randomized to receive a placebo followed by 2 doses of CYD Dengue vaccine
nacl + cyd dengue vaccine
0.5 mL, Subcutaneous at Day 0 (placebo), 6 and 12 months (CYD), respectively
(Experimental)
Participants randomized to receive 2 doses of placebo followed by 1 dose of CYD Dengue vaccine
nacl + cyd dengue vaccine
0.5 mL, Subcutaneous at Day 0 and Month 6 (placebo), 12 months (CYD), respectively

Primary Outcomes

Measure
Summary of Neutralizing antibody titers against each dengue virus serotype 28 days after the last CYD dengue vaccine injection in each Group primary series schedules
time frame: 28 days after the last CYD dengue vaccine
Summary of Neutralizing antibody titers against each dengue virus serotype 28 days post booster dose (Year 1 and Year 2, respectively, for each group tested in STAGE II)
time frame: 28 days after the booster vaccination

Secondary Outcomes

Measure
Number of subjects with seroconversion 28 days after injection for each of the 4 parental dengue virus strains of CYD dengue vaccine
time frame: 28 Days post each vaccination
Summary of neutralizing antibody titers against each dengue virus serotype immediately prior to booster dose and post booster in all 3 CYD vaccination groups
time frame: 28 days after the booster vaccination
Number of participants reporting solicited injection site reactions, solicited systemic reactions, unsolicited adverse events, and serious adverse events occurring during trial
time frame: Day 0 up to 2 years post vaccination

Eligibility Criteria

Male or female participants from 9 years up to 50 years old.

Inclusion Criteria: - Aged 9 to 50 years on the day of enrollment - Subject in good health, based on medical history and physical examination - Assent form or informed consent form (ICF) has been signed and dated by the subject (based on local regulations), and ICF has been signed and dated by the parent(s) or another legally acceptable representative (and by an independent witness if required by local regulations) - Subject and parent(s)/legally acceptable representative(s) able to attend all scheduled visits and to comply with all trial procedures. Exclusion Criteria: - Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be pre-menarche, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination until at least 4 weeks after the last vaccination) - Participation at the time of study enrollment (or in the 4 weeks preceding the first trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device or medical procedure - Self-reported or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) - Self-reported systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances - Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion - Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response - Planned receipt of any vaccine in the 4 weeks following any trial vaccination - Previous vaccination against dengue disease with either the trial vaccine or another vaccine - Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily - Current alcohol abuse or drug addiction that, based on investigator's judgment, may interfere with the subject´s ability to comply with trial procedures. - Identified as a site employee of the Investigator, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members (i.e. ,immediate, husband, wife, and their children, adopted or natural) of the employees or the Investigator - A prospective subject must not be included in the study until the following conditions and/or symptoms are resolved: - Febrile illness (temperature ≥ 38.0°C) or moderate or severe acute illness/infection (according to Investigator's judgment) on the day of vaccination. - Receipt of any vaccine in the 4 weeks preceding the first trial vaccination.

Additional Information

Official title Immunogenicity and Safety of Tetravalent Dengue Vaccine Given in 1 , 2 , or 3 Dose Schedules (STAGE I) Followed by a Single Booster Injection of the Same Vaccine (STAGE II) 1 or 2 Years After the Last Primary Dose in Healthy Subjects 9 to 50 Years of Age in Colombia and the Philippines
Description Healthy subjects between age 9 and 50 year will receive in various schedules of CYD vaccine and placebo administration over a 12-month period. They will be further randomized to receive a single booster vaccination of CYD vaccine at either 12 months or 24 months following the last primary series injection.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Sanofi.